Tags: Life Sciences
Belgian Pharma Law Summer Blog Series (Part 3): the recently passed ‘Bill containing various provisions on health’
In our Belgian Pharma Law Summer Blog Series, we examine recent developments in Belgian pharmaceutical law. Whether you are looking for an informative summer read or a concise overview of the latest legal developments to catch up on after the holidays, our series has you covered. Our third and final part examines the ‘Bill containing […]
Belgian Pharma Law Summer Blog Series (Part 2): the new ‘Article 10 guidance’ on pharmaceutical promotion
In our Belgian Pharma Law Summer Blog Series, we examine recent developments in Belgian pharmaceutical law. Whether you are looking for an informative summer read or a concise overview of the latest legal developments to catch up on after the holidays, our series has you covered. Part 2 focuses on the new guidance on the […]
Belgian Pharma Law Summer Blog Series (Part 1): the Act of 30 May 2026 containing various provisions on medicinal and health products
In our Belgian Pharma Law Summer Blog Series, we examine recent developments in Belgian pharmaceutical law. Whether you are looking for an informative summer read or a concise overview of the latest legal developments to catch up on after the holidays, our series has you covered. Part 1 focuses on the Act of 30 May […]
New EU sample retention rules coming up for veterinary medicines repackaged for parallel trade
The Veterinary Medicinal Products Regulation (EU) 2019/6 has applied in the EU since 28 January 2022, replacing Directive 2001/82/EC. The new rules on good manufacturing practice (GMP) will in turn be fleshed out by Commission Implementing Regulation (EU) 2025/2091, which will apply from 16 July 2026. In addition, the European Commission is introducing new GMP requirements concerning the retention of samples for veterinary medicinal products that are repackaged for parallel trade. This blog post briefly examines what these new obligations entail.
Agri-food Law Seminar 2026
We are excited to announce that our annual Agri-food Law Seminar will return to Brussels on 5 June 2026!
EU General Court bars patient association from challenging medicine authorisation refusal
In Case T‑278/25, the EU General Court recently dismissed as inadmissible a challenge brought by a patient advocacy association against the European Commission’s refusal to renew the conditional marketing authorisation for a treatment against Duchenne muscular dystrophy (DMD). The case is significant because it adds to the case law on contesting Commission decisions relating to the marketing of medicinal products. In this blog post, we look at how the Court came to the conclusion that the association lacked standing to litigate and use this as a basis for an informal categorisation of the existing case law.
Despite EU harmonisation, Member States may impose authorisation requirements on pharmacy-prepared medicines, rules EU Court of Justice
Under EU pharmaceutical law, certain medicines fall outside the scope of Directive 2001/83/EC (i.e. the Community code on medicinal products for human use). This includes “magistral formulae” (prepared in a pharmacy for an individual patient on prescription) and “officinal formulae” (prepared in a pharmacy in accordance with a pharmacopoeia and supplied directly to that pharmacy’s […]
EU General Court: technical vaccine data does not have to be disclosed on request
The EU General Court delivered a significant judgment concerning access to documents held by the European Medicines Agency (EMA), this time relating to a conditionally authorised COVID-19 vaccine. This case (T-623/22) serves as an addition to the elaborate case law on the balance between transparency in health matters and the protection of companies’ commercial interests. On this (rare) occasion, the commercial interests of the conditional marketing authorisation (‘MA’) holder prevailed, although an appeal is currently pending (C-38/26 P).
Belgium’s healthcare plans for 2026 – and where pharma fits in
Every year, Belgium’s federal ministers publish their policy notes for discussion in Parliament. They give a high-level snapshot of what each minister plans to focus on in the coming year. For the pharmaceutical industry, the healthcare policy noteis usually the one to watch. Interestingly, the economic policy notealso weighs in on pharma this year. In this blog post, we unpack the key policy signals for the pharmaceutical sector and group them around three main pillars: budget, accessibility, andpricing.
Where food law meets intellectual property: Food IP through last year’s case law
Government decisions can often have a significant impact on companies in the agrifood and life sciences sectors. But what options do you have if you disagree with such a decision? Which steps are available to you, and which route – administrative or judicial – is the most suitable in your case?
Belgian Parliament has adopted urgent 2026 healthcare budget measures: what’s the impact on the pharma industry?
Over the Christmas break, the Belgian Parliament adopted an urgent law with several measures linked to the approved 2026 healthcare budget, with effect from 1 January 2026. The law is intentionally limited to provisions that must enter into force immediately to ensure that the required savings and revenues are available from the start of the […]
EU Reaches Pharma Package Deal: Key Changes at a Glance
On 11 December 2025, following overnight negotiations, the Council and the European Parliament announced a political agreement on the long-awaited Pharma Package (see here). The reform seeks to update the EU’s pharmaceutical rulebook to facilitate access to safe and affordable treatments and bolster the life sciences sector’s competitiveness. While more detailed information is still trickling […]